Model Number ED34-I10T2 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 02/21/2024 |
Event Type
Injury
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Event Description
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Pentax medical was made aware of a complaint on (b)(6) 2024 that occurred during treatment in the united states involving a pentax medical sterile distal end cap(dec) model: oe-a63, lot number: 0011112 or 0021122.The sterile single use distal cap was used with pentax medical video duodenoscope, model: ed34-i10t2, serial number: (b)(6).The customer reported that after a procedure their patient spat out from their mouth the oe-a63 sterile distal end cap.The physician attached the oe-a63 to the ed34-i10t2 duodenoscope prior to the procedure start.However, the procedure was able to be performed to completion, without any issues during the case.There was no reported harm to the patient and the patient was not recalled for further screening.This event meets the requirements for fda reportability; however, submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.
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Manufacturer Narrative
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H6 continued: international medical device regulators forum (imdrf) adverse event reporting.Health effect clinical code: 3165 device embedded in tissue or plaque.Health effect impact code: 2199 no health consequences or impact.Medical device problem code: 2907 detachment of device or device component.Component code: 424 cap.Type of investigation: 4118 type of investigation not yet determined.Investigation findings: 3233 results pending completion of investigation.Investigation conclusions: 11 conclusion not yet available.Customer did not record any of the lot numbers in any of the patient charts when this occurred.At this time they do not have traceability on the distal caps on which lot number was used.Per the account, they only have two lot numbers of sterile distal end cap model #: oe-a63 on site.Lot #: 0011112 & 0021122.Therefore, the d4 lot number is listed as #: 0011112 or 0021122, two lot numbers.Pentax medical america performed good faith effort to gather additional information regarding this event and provided an email response on 28-feb-2024 with the following information.Q1.Was the procedure for treatment or diagnostic purposes? a: treatment.Q2.Was there a delay in the procedure which would require medical intervention such as additional anesthesia or prolonged hospital stay? a: no.Q3.Was the product in question used to complete the procedure? a: yes.Q4.Please confirm if the fallen cap#: oe-a63 was retrieved from the patient's body or not? a: yes.Q5.If retrieved, how did the doctor retrieve it? (using another medical device etc.) a: patient spit it out.Q6: did a nurse attach the cap#: oe-a63 to the distal part of the endoscope? if so, did they hear the clicking sound when attaching it? a: doctor.Q7: how does the user consider the cause of the fallen cap#: oe-a63? a: unknown.Q8: does this facility have a pentax service contract? a:expired 1/31/2024.Q9: was there a time prolongation of the procedure for retrieving the cap? no.Q10: did they receive the information and training about the proper use of cap#: oe-a63? a: unknown.Q11: was the patient recalled for further screening? a: no.Q12: if no, will the patient be recalled for further screening? a: unknown.Q13: what is the current status of the patient? a: unknown.Q14: was the product removed from circulation immediately after the failure/event occurred and subsequently called in for service/replacement? a: yes.Q15: device current location and status? a: in managers office.Q16: is it possible to return the fallen retrieved cap? a: no.Q17: pre-procedural checks and use for the product involved? a: yes.Q18: reprocessing ifu? a: yes.Q19: any accessory involved ifu? a: n/a.Q20: reprocessing procedure: a: manual and automated.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.Manufacturer mdr 9610877-2024-00020, dec distal cap model: oe-a63, lot number: 0011112 or 0021122.Duodenoscope model: ed34-i10t2, serial number: (b)(6).
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Manufacturer Narrative
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H6 continued:
international medical device regulators forum (imdrf) adverse event reporting
health effect clinical code: 3165 device embedded in tissue or plaque
health effect impact code: 2199 no health consequences or impact
medical device problem code: 2907 detachment of device or device component
component code: 424 cap
type of investigation: 4111 communication/interviews
investigation findings: 114 operational problem identified
investigation conclusions: 19 cause traced to user
correction information
b4: date of this report
h2:if follow-up, what type?
h3:device evaluated by manufacture
h6: coding changed based on the investigation result
additional information
d4:unique identifier (udi) corrected
h4:device manufacture date
h11: evaluation summary
evaluation summary
the investigation determined that the distal end cap (dec) was not properly attached by the user and the endoscope most likely
came into contact with the teeth or mouthpiece when it was taken out of the mouth, causing the dec to fall into the mouth due to
the impact.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured pentax medical miyagi on 12-nov-2021 under normal conditions,
passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed on
12-nov-2021.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.Manufacturer mdr 9610877-2024-00020, dec distal cap model oe-a63 lot number 0011112 or 0021122
manufacturer mdr 9610877-2024-00021, duodenoscope model ed34-i10t2 serial number q111129.
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Search Alerts/Recalls
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